China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) announced that its Phase III SHR6390-III-302 study for dalpiciclib, a cyclin-dependent kinase 4 and 6 (CDK 4/6) inhibitor, has met pre-set superiority criteria. The drug, combined with letrozole or anastrozole, significantly prolonged progression-free survival (PFS) in patients with HR-positive, HER2-negative advanced breast cancer.
Study Details
The multi-center, randomized, double-blind trial enrolled 456 patients at a 2:1 ratio. Primary endpoint: investigator-evaluated PFS. Secondary endpoints included overall survival (OS), objective response rate (ORR), clinical benefit rate (CBR), duration of response (DOR), and safety. Results showed dalpiciclib plus an aromatase inhibitor as initial therapy significantly extended PFS.
Drug Profile
Dalpiciclib, China’s first homegrown CDK 4/6 inhibitor, received market approval in December 2021 for HR-positive, HER2-negative recurrent/metastatic breast cancer post-endocrine therapy, combined with fulvestrant.
Market Context
Global sales of similar CDK 4/6 inhibitors—Pfizer’s Ibrance (palbociclib), Eli Lilly’s Verzenio (abemaciclib), G1 Therapeutics’ trilaciclib, and Novartis’s ribociclib—reached USD 7.735 billion in 2021.-Fineline Info & Tech
